Le Lézard
Classified in: Health, Science and technology, Business
Subjects: EARNINGS, Conference Call, Webcast

2seventy bio Reports Second Quarter Financial Results and Recent Operational Progress


2seventy bio, Inc. (Nasdaq: TSVT), a leading immuno-oncology cell therapy company, today reported financial results and recent highlights for the second quarter ended June 30, 2022.

"As 2seventy continues our first year as a new company, we remain on a solid growth trajectory with ongoing progress commercially with ABECMA and across our pipeline," said Nick Leschly, chief kairos officer. "We were extremely pleased to announce this morning that the prespecified interim analysis of our KarMMa-3 Phase 3 study of ABECMA met the primary endpoint of progression-free survival with a safety profile that was consistent with prior studies. We look forward to sharing these results with regulators with the goal of treating multiple myeloma patients in earlier lines. We will share additional data from the KarMMa-3 study, our plans for future investment in ABECMA, and pipeline and portfolio updates throughout 2H22 as we continue our mission to develop innovative, un-incremental treatments for people living with cancer."

ABECMA Commercial Summary and Business Update

Bristol Myers Squibb (BMS) reported total U.S. ABECMA (idecabtagene vicleucel; ide-cel) second quarter revenues of $72 million, representing 29% growth over the prior quarter. We continue to experience strong commercial demand and remain on track to achieve the upper end of our stated 2022 U.S. ABECMA revenue guidance of $250-300M. Given the continued strong demand and our growing belief in the potential for ABECMA to play an important role in earlier lines, we are continuing to advance our manufacturing strategy to expand capacity across the supply chain.

We reported share of collaboration loss of $4.3 million for the second quarter, which includes our share of gross profit/loss less costs associated with the commercialization of ABECMA in the U.S. In 2022, the collaboration experienced increased ABECMA manufacturing costs driven primarily by higher than anticipated vector costs. This has resulted in higher charges to 2seventy as part of our 50% share of U.S. costs with BMS. BMS is actively working with the vector manufacturer to lower costs and increase manufacturing capacity and 2seventy is supporting BMS in this work. Vector supply remains on track to meet our commercial plan for 2022 and we are continuing to invest in increasing manufacturing capacity in the future.

Given the increase in ABECMA costs that are shared by BMS with 2seventy, we are increasing our net cash spend guidance for 2022 to $245-265 million. All other spend for the rest of our business continues to track in line with previous guidance. We continue to forecast cash runway into 2025 based on current operating plans. This runway is sufficient to achieve important milestones across our business.

RECENT HIGHLIGHTS

UPCOMING ANTICIPATED MILESTONES

SELECT SECOND QUARTER 2022 FINANCIAL RESULTS

Conference Call Information

2seventy bio will host a conference call and live webcast today, August 10, at 8:00 a.m. ET to discuss 2Q 2022 financial results and recent business highlights. To access the conference call, please register at: https://register.vevent.com/register/BI3e6a40291152487788cdc808e17e6e59. Upon registering, each participant will be provided with call details and access codes. The live webcast may be accessed by visiting the event link at: https://edge.media-server.com/mmc/p/hmxheiqe. A replay of the webcast may be accessed from the News and Events page in the Investors and Media section of the company's website at https://ir.2seventybio.com/. A replay will be archived on 2seventy bio's site for 30 days following the event.

About 2seventy bio

Our name, 2seventy bio, reflects why we do what we do - TIME. Cancer rips time away, and our goal is to work at the maximum speed of translating human thought into action ? 270 miles per hour ? to give the people we serve more time. We are building the leading immuno-oncology cell therapy company, focused on discovering and developing new therapies that truly disrupt the cancer treatment landscape.

With a deep understanding of the human body's immune response to tumor cells and how to translate cell therapies into practice, we're applying this knowledge to deliver next generation cellular therapies that focus on a broad range of hematologic malignancies, including the first FDA-approved CAR T cell therapy for multiple myeloma, as well as solid tumors. Our research and development is focused on delivering therapies that are designed with the goal to "think" smarter and faster than the disease. Importantly, we remain focused on accomplishing these goals by staying genuine and authentic to our "why" and keeping our people and culture top of mind every day.

For more information, visit www.2seventybio.com.

Follow 2seventy bio on social media: Twitter and LinkedIn.

2seventy bio is a trademark of 2seventy bio, Inc.

Cautionary Note Regarding Forward-Looking Statements

This release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. These statements include, but are not limited to: statements about our plans, strategies, timelines and expectations with respect to the development, manufacture or sale of our product candidates, including the results and expected timing of ongoing and planned clinical trials for our product candidates and for ABECMA (ide-cel) in additional indications; statements about the efficacy and perceived therapeutic benefits of our product candidates and the potential indications, market opportunities and demand therefor; statements about the strategic plans for 2seventy bio and potential corporate development opportunities including collaboration arrangements; statements regarding the company's financial condition, expenses, results of operations, expectations regarding use of capital, cash runway and other future financial results; and statements about our ability to execute our strategic priorities. Any forward-looking statements in this press release are based on management's current expectations and beliefs and are subject to a number of risks, uncertainties and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press release, including, without limitation, our limited independent operating history and the risk that our accounting and other management systems may not be prepared to meet the financial reporting and other requirements of operating as an independent public company; the risk that dedicated financial and/or strategic funding sources may not be available on favorable terms or at all; the risk that the separation may adversely impact our ability to attract or retain key personnel; the risk that our BLAs and INDs will not be accepted for filing by the FDA on the timeline that we expect, or at all; the risk that our plans with respect to the preclinical and clinical development and regulatory approval of our product candidates may not be successfully achieved on the planned timeline, or at all; the risk that ABECMA will not be as commercially successful as we may anticipate; and the risk that we are unable to manage our operating expenses or cash use for operations. For a discussion of other risks and uncertainties, and other important factors, any of which could cause our actual results to differ from those contained in the forward-looking statements, see the section entitled "Risk Factors" in our annual report on Form 10-K for the year ended December 31, 2021, as supplemented and/or modified by our most recent Quarterly Report on Form 10-Q and any other filings that we have made or will make with the Securities and Exchange Commission in the future. All information in this press release is as of the date of the release, and 2seventy bio undertakes no duty to update this information unless required by law.

2seventy bio, Inc.
Condensed Consolidated and Combined Statements of Operations and Comprehensive Loss

(unaudited)

(in thousands)

For the three months ended June 30, For the six months ended June 30,

 

2022

 

 

2021

 

 

2022

 

 

2021

 

Revenue:
Service revenue

$

5,666

 

$

5,314

 

$

9,721

 

$

11,232

 

Collaborative arrangement revenue

 

7,035

 

 

1,671

 

 

10,522

 

 

3,190

 

Royalty and other revenue

 

781

 

 

343

 

 

1,668

 

 

4,807

 

Total revenues

 

13,482

 

 

7,328

 

 

21,911

 

 

19,229

 

Operating expenses:
Research and development

 

68,439

 

 

63,692

 

 

137,684

 

 

141,263

 

Selling, general and administrative

 

17,278

 

 

21,402

 

 

41,139

 

 

46,029

 

Share of collaboration loss

 

4,290

 

 

10,071

 

 

9,642

 

 

10,071

 

Cost of royalty and other revenue

 

364

 

 

87

 

 

875

 

 

1,791

 

Change in fair value of contingent consideration

 

83

 

 

47

 

 

131

 

 

416

 

Total operating expenses

 

90,454

 

 

95,299

 

 

189,471

 

 

199,570

 

Loss from operations

 

(76,972

)

 

(87,971

)

 

(167,560

)

 

(180,341

)

Interest income, net

 

213

 

 

-

 

 

328

 

 

-

 

Other (loss) income, net

 

(644

)

 

3,929

 

 

4,118

 

 

9,103

 

Loss before income taxes

 

(77,403

)

 

(84,042

)

 

(163,114

)

 

(171,238

)

Income tax (expense) benefit

 

(17

)

 

-

 

 

(17

)

 

-

 

Net loss

$

(77,420

)

$

(84,042

)

$

(163,131

)

$

(171,238

)

Net loss per share - basic and diluted

$

(2.02

)

$

(3.60

)

$

(5.00

)

$

(7.33

)

Weighted-average number of common shares used in computing net loss per share - basic and diluted

 

38,381

 

 

23,369

 

 

32,598

 

 

23,369

 

2seventy bio, Inc.
Condensed Consolidated Balance Sheet Data
(unaudited)
(in thousands)
 

As of June 30, 2022

As of December 31, 2021

Cash, cash equivalents and marketable securities

$

398,566

$

362,181

Total assets

 

787,406

 

759,675

Total liabilities

 

408,422

 

399,853

Total stockholders' equity

 

378,984

 

359,822

 


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News published on 10 august 2022 at 06:55 and distributed by: